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Virus Therapy

Letermovir Prophylaxis for Cytomegalovirus Infection in Heart Transplant Recipients

Phase 4
Waitlist Available
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Heart transplant recipients who are not CMV donor negative and CMV recipient negative (CMV -/-)
Adults between 18-70 will be eligible for participation
Must not have
Has Child Pugh Class C severe hepatic insufficiency at screening
On CVVH or renal dialysis at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will compare the rates of CMV infection and disease in 30 heart transplant patients who will be given letermovir as prophylaxis to a retrospective cohort of 374 heart transplant patients. The tolerability of letermovir will also be assessed.

Who is the study for?
This trial is for adults aged 18-70 who have recently received a heart transplant and are at risk for cytomegalovirus, but not HIV positive or on dialysis. They mustn't be allergic to letermovir, participating in other clinical trials with investigational drugs, or planning to donate eggs/sperm within 90 days after the study.
What is being tested?
The trial tests Letermovir as a preventive measure against CMV infection in heart transplant recipients. It compares outcomes of a new group of 30 patients with those from a past group of 374 patients, focusing on rates of neutropenia and drug tolerability.
What are the potential side effects?
While specific side effects aren't listed here, typically antiviral medications like Letermovir could cause symptoms such as headache, nausea, vomiting, diarrhea; potential blood issues like neutropenia; and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a heart transplant and either I or my donor was not CMV negative.
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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver is not working well (severe issues).
Select...
I am currently on dialysis.
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I have received both a heart and kidney transplant.
Select...
I am HIV positive.
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My kidney function is low, with a creatinine clearance under 10 ml/min.
Select...
I have moderate liver and kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients with neutropenia
Secondary study objectives
Measure of CMV specific T cell immunity in letermovir recipients compared to controls
Rate of CMV infection in letermovir recipients
Rate of opportunistic infections in letermovir arm compared to historic controls
+2 more

Side effects data

From 2016 Phase 3 trial • 570 Patients • NCT02137772
39%
Graft versus host disease
29%
Diarrhoea
28%
Nausea
24%
Rash
23%
Pyrexia
21%
Vomiting
17%
Cough
16%
Oedema peripheral
16%
Headache
15%
Cytomegalovirus infection
15%
Fatigue
13%
Abdominal pain
12%
Mucosal inflammation
12%
Decreased appetite
10%
Blood creatinine increased
10%
Dyspnoea
9%
Hypertension
9%
Acute kidney injury
9%
Oropharyngeal pain
9%
Insomnia
9%
Erythema
8%
Febrile neutropenia
8%
Hyperkalaemia
8%
Asthenia
8%
Hyperglycaemia
8%
Constipation
8%
Arthralgia
8%
Dizziness
8%
Tremor
8%
Dry skin
8%
Pruritus
7%
Alanine aminotransferase increased
7%
Epistaxis
7%
Thrombocytopenia
6%
Dyspepsia
6%
Stomatitis
6%
Bacteraemia
6%
Aspartate aminotransferase increased
6%
Acute myeloid leukaemia recurrent
6%
Anaemia
6%
Dry eye
6%
Abdominal pain upper
6%
Dry mouth
6%
Hypokalaemia
6%
Hypomagnesaemia
6%
Hyponatraemia
6%
Back pain
6%
Myalgia
6%
Anxiety
5%
Nasopharyngitis
5%
Dysuria
5%
Neutropenia
5%
Chest pain
5%
Pain in extremity
5%
Dysgeusia
4%
Hypotension
4%
Pneumonia
4%
Rhinorrhoea
3%
Viraemia
3%
Muscle spasms
2%
Gastrooesophageal reflux disease
2%
Acute lymphocytic leukaemia recurrent
2%
Respiratory failure
2%
Sepsis
2%
Acute myeloid leukaemia
1%
Hepatic function abnormal
1%
Pneumonia bacterial
1%
Gastrointestinal haemorrhage
1%
Viral haemorrhagic cystitis
1%
Multiple organ dysfunction syndrome
1%
Sinusitis
1%
Staphylococcal bacteraemia
1%
Urinary tract infection
1%
Pneumothorax
1%
Venoocclusive liver disease
1%
Plasma cell myeloma recurrent
1%
Squamous cell carcinoma
1%
Gastroenteritis
1%
Herpes zoster
1%
Pleural effusion
1%
Pancytopenia
1%
Bronchopulmonary aspergillosis
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Transplant failure
1%
Myelodysplastic syndrome
1%
Epstein-Barr virus infection
1%
Gastroenteritis viral
1%
Rhinovirus infection
1%
Septic shock
1%
Neurotoxicity
1%
Acute lymphocytic leukaemia
1%
Mantle cell lymphoma
1%
Sciatica
1%
Syncope
1%
Cystitis haemorrhagic
1%
Acute respiratory distress syndrome
1%
Venoocclusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Letermovir

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: single armExperimental Treatment1 Intervention
Letermovir 480 mg daily for cmv prophylaxis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir
2019
Completed Phase 3
~1530

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
263 Previous Clinical Trials
264,430 Total Patients Enrolled
2 Trials studying Infections
149 Patients Enrolled for Infections
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,212 Total Patients Enrolled
177 Trials studying Infections
586,660 Patients Enrolled for Infections

Media Library

Letermovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04904614 — Phase 4
Infections Research Study Groups: single arm
Infections Clinical Trial 2023: Letermovir Highlights & Side Effects. Trial Name: NCT04904614 — Phase 4
Letermovir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04904614 — Phase 4
~7 spots leftby Oct 2025
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